METHERGINE- methylergonovine maleate tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

METHYLERGONOVINE MALEATE (UNII: IR84JPZ1RK) (METHYLERGONOVINE - UNII:W53L6FE61V)

Disponível em:

Lupin Pharmaceuticals,Inc.

DCI (Denominação Comum Internacional):

METHYLERGONOVINE MALEATE

Composição:

METHYLERGONOVINE MALEATE 0.2 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder. Hypertension; toxemia; pregnancy; and hypersensitivity. Methergine (methylergonovine maleate) has not been associated with drug abuse or dependence of either a physical or psychological nature.

Resumo do produto:

White, round, biconvex compressed tablets debossed with "n" on one side and "01" on the other side.  Available in bottles of 7, 12, 28 and 100 tablets. Bottles of 7………………………………NDC   27437-050-19 Bottles of 12…………………………….NDC   27437-050-57 Bottles of 28…………………………….NDC   27437-050-56 Bottles of 100………………………...…NDC   27437-050-01 STORE AND DISPENSE Tablets: Store below 25°C (77°F); in tight, light-resistant container. Methergine is a registered trademark of Novartis AG Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharma Baltimore, MD 21202 PI1400003901 Iss. 01/2016

Status de autorização:

Abbreviated New Drug Application

Características técnicas

METHERGINE- METHYLERGONOVINE MALEATE TABLET
LUPIN PHARMACEUTICALS,INC.
----------
METHERGINE®
(METHYLERGONOVINE MALEATE) TABLETS, USP
RX ONLY
DESCRIPTION
Methergine (methylergonovine maleate) is a semi-synthetic ergot
alkaloid used for the
prevention and control of postpartum hemorrhage.
Methergine is available in tablets for oral ingestion containing 0.2
mg methylergonovine
maleate.
TABLETS
_Active ingredient: _Methylergonovine maleate, USP, 0.2 mg.
_Inactive ingredients: _acacia, corn starch, gelatin, lactose
monohydrate, methylparaben,
microcrystalline cellulose, povidone, propylparaben, stearic acid, and
tartaric acid.
Chemically, methylergonovine maleate is designated as
ergoline-8-carboxamide, 9, 10-
didehydro-_N_-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(_S_)]-,
(Z)-2-butenedioate (1:1)
(salt).
Its structural formula is:
CLINICAL PHARMACOLOGY
Methergine (methylergonovine maleate) acts directly on the smooth
muscle of the
uterus and increases the tone, rate, and amplitude of rhythmic
contractions. Thus, it
induces a rapid and sustained tetanic uterotonic effect which shortens
the third stage of
labor and reduces blood loss. The onset of action after I.V.
administration is immediate;
after I.M. administration, 2-5 minutes, and after oral administration,
5-10 minutes.
®
Pharmacokinetic studies following an I.V. injection have shown that
methylergonovine is
rapidly distributed from plasma to peripheral tissues within 2-3
minutes or less. The
bioavailability after oral administration was reported to be about 60%
with no
accumulation after repeated doses. During delivery, with intramuscular
injection,
bioavailability increased to 78%. Ergot alkaloids are mostly
eliminated by hepatic
metabolism and excretion, and the decrease in bioavailability
following oral administration
is probably a result of first-pass metabolism in the liver.
Bioavailability studies conducted in fasting healthy female volunteers
have shown that
oral absorption of a 0.2 mg methylergonovine tablet was fairly rapid
with a mean peak
plas